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Background: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare., Methods: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed., Results: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months., Conclusion: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits., Trial Registration: ClinicalTrials.gov identifier: NCT01448785.

Background: Access port problems after laparoscopic adjustable gastric banding can be significant complications. The Easyband™ is an innovative type of gastric band, whose internal diameter can be adjusted by a telemetrically activated motor. The aim of this study was to evaluate safety, efficacy and performance of the Easyband™., Methods: A total of 110 morbidly obese patients were prospectively enrolled. The Easyband™ was implanted laparoscopically by experienced bariatric surgeons in six different hospital locations. Patient characteristics, surgery details, postoperative weight loss, and complications were recorded. Follow-up lasted 2 years., Results: Follow-up was completed by 78.2 % of the patients. Surgeons rated 71 % of each aspect of Easyband™ implantation as "easy" or "very easy". Adjustments were successful in 91 % of the attempts. One or more adverse events occurred in 79.1 % of the patients. Thirty-six serious adverse events were reported, of which 50 % was device-related. One or more functional tests failed in 20.9 % of the devices, 8.2 % passed after a repeated test. A reintervention was necessary in 15.5 % of the patients. Mean weight loss after 2 years was 24.2 ± 14.0 kg, mean excess weight loss was 46.1 ± 24 %., Conclusion: Excess weight loss with the Easyband™ was comparable with other gastric banding devices. Adjustment of the device was simple, non-invasive and more acceptable to patients than with a standard access port. However, a high incidence of device-related problems requiring surgical explantation occurred. The Easyband™ represents a major advance in gastric band design, but significant technical problems need to be resolved before further implants can be recommended.

The prevalence of obesity continues to escalate in the USA; however, there is no consensus regarding the optimal therapy for obesity. For the vast majority of severely obese patients, conventional medical therapies (i.e., diet, exercise, behavioral counseling) often fail over the long term. Existing pharmacotherapy adjunctive to behavioral therapy has limited effectiveness and an imperfect safety record. In contrast, bariatric surgery has a high degree of weight loss efficacy, yet only a small fraction of the qualifying obese population undergoes these procedures because of the associated perioperative risks and potential late complications. In addition, the role of bariatric surgery is unclear in certain patient populations, such as patients with lower body mass index (BMI, 30-35 kg/m(2)), the high-risk super-super obese patients (BMI > 60), the morbidly obese adolescent, and obese patients requiring weight reduction in preparation for other procedures, such as orthopedic, transplant, or vascular surgeries. In these circumstances, there is a need for an effective but less invasive treatment to bridge the gap between medical and surgical therapy. This review examines current treatment outcomes, identifies prominent areas of unmet clinical needs, and provides an overview of two minimally invasive "temporary procedures for weight loss" that may eventually address some of the unmet needs in obesity management.

Background: Increasing numbers of pregnancies are seen in obese women treated surgically with laparoscopic adjustable gastric banding (LAGB). We compared their maternal and fetal outcomes with obese women without LAGB and normal-weight controls., Methods: Sixty-nine obese women with LAGB (83 pregnancies) were compared with 120 obese women without LAGB and 858 controls., Results: By comparison with normal controls, post-LAGB pregnancies had higher rates of gestational hypertension (9.6% vs 2.4%, p < 0.05), preeclampsia/eclampsia (12.0% vs 2.3%, p < 0.001), abortion (10.8% vs 0.3%, p < 0.001), cesarean section (45.9% vs 28.2%, p < 0.01), preterm delivery (17.6% vs 3.6%, p < 0.001), and babies needing neonatal intensive care (20.3% vs 9.0%, p < 0.01). Compared with the no-LAGB obese group, the post-LAGB pregnancies had lower rates of gestational hypertension (9.6% vs 23.5%, p < 0.05), preeclampsia/eclampsia (12.0% vs 20.8%, p < 0.05), and cesarean section (45.9% vs 65.8%, p < 0.01). The post-LAGB obese women gained less weight during the pregnancy (6.6 +/- 7.9 vs 14.8 +/- 10.1 kg, p < 0.001) and experienced less gestational hypertension (14.8% vs 33%), preeclampsia/eclampsia (7.4% vs 14.8%), and macrosomia (4.2% vs 16%) than in pregnancies before LAGB. No significant differences in maternal and fetal outcomes emerged between post-LAGB pregnant women who lost versus those who gained weight during pregnancy. Compared with those no longer morbidly obese, women still morbidly obese after LAGB had a lower weight gain (2.8 +/- 11.8 vs 8.6 +/- 9.5 kg, p < 0.05) and a higher gestational hypertension rate (29.4% vs 8.9%, p < 0.05)., Conclusion: The risks of negative maternal and fetal outcomes for obese women can be reduced by LAGB if the women are closely followed up.

Background: Small dense low-density lipoprotein (LDL) are atherogenic particles frequently observed in obese patients. Fatty acids modulate LDL. Objective of this study was to determine the relations between plasma phospholipid fatty acid composition and the presence of small dense LDL particles in morbidly obese patients treated with laparoscopic gastric banding (LAGB)., Methods: Small dense LDL, plasma lipids, lipoproteins, apoproteins, and phospholipid fatty acid composition (a marker of dietary fatty acid intake) were quantified before and 12 months after surgery in four men and 11 women who were morbidly obese and (BMI > 40 kg/m(2)) eligible for surgery, consecutively treated with LAGB at the Department of Medical and Surgical Sciences of the University of Padova., Results: BMI was 48.3 +/- 4.8 kg/m(2) before and 36.1 +/- 5.5 kg/m(2) after LAGB. Plasma triglycerides and apoprotein E levels significantly decreased, while HDL cholesterol significantly increased after LAGB. A reduction of small dense LDL with an increase of LDL relative flotation (0.34 +/- 0.04 before vs 0.38 +/- 0.03 after LAGB, p < 0.001) was also observed. These modifications were neither related to weight reduction nor to changes in phospholipid fatty acid composition, but they were associated to triglyceride reduction, which explained 76.7% of the LDL relative flotation variation., Conclusion: Weight loss obtained by LAGB in morbidly obese subjects was accompanied by triglyceride reduction, high-density lipoprotein increase, and an improvement of the atherogenic LDL profile. Triglyceride reduction, but not the extent of weight loss or dietary fatty acid modifications, is the determinant of modifications of LDL physical properties in these patients.

Preoperative psychological screening of bariatric surgery candidates has become routine, and a significant proportion of patients have their surgery deferred as a consequence. If psychological testing is being used as a form of preoperative triage, both patients and surgeons are entitled to know whether there is sufficient evidence to justify its use in this way. We define the argument for psychological screening as consisting of four premises (p1-p4) and a conclusion (C) as follows: (p1) A significant minority of obese patients will not be successful in losing weight following bariatric surgery-the "failure" group; (p2) A significant minority of patients will exhibit abnormal psychological profiles during preoperative testing; (p3) The majority of individuals referred to in (p2) will be found in group (p1) i.e., abnormal psychological profiles identified preoperatively predict less favorable weight loss outcomes postoperatively; (p4) Identifying patients with adverse psychological profiles preoperatively would allow either exclusion of those at high risk of failure or provide a more secure rationale for targeted pre- and postoperative support; (C) Psychological screening should be part of the routine preoperative assessment for patients undergoing obesity surgery. We reviewed the literature to find evidence to support the premises and show that (p1) can be justified but that (p2) is problematic and can only be accepted in a heavily qualified version. We find no evidence for (p3) and since (p4) and (C) are predicated on (p3), the argument clearly fails. There is no evidence to suggest that preoperative psychological screening can predict postoperative outcomes and no justification for using such testing as a means of discriminating between candidates presenting themselves for bariatric surgery.

Background: This study examines 1,791 consecutive laparoscopic adjustable gastric banding (LAGB) procedures with up to 12 years follow-up. Long-term results of LAGB with a high follow-up rate are not common., Methods: Between September 1993 and December 2005, 1,791 consecutive patients (75.1% women, mean age 38.7 years, mean weight 127.7 +/- 24 kg, mean BMI 46.2 +/- 7.7) underwent LAGB by the same surgical team. Perigastric dissection was used in 77.8% of the patients, while subsequently pars flaccida was used in 21.5% and a mixed approach in 0.8%. Data were analyzed according to co-morbidities, conversion, short- and long-term complications and weight loss. Fluoroscopy-guided band adjustments were performed and patients received intensive follow-up. The effects of LAGB on life expectancy were measured in a case/control study involving 821 surgically-treated patients versus 821 treated by medical therapy., Results: Most common baseline co-morbidities (%) were hypertension (35.6), osteoarthritis (57.8), diabetes (22), dyslipidemia (27.1), sleep apnea syndrome (31.4), depression (21.2), sweet eating (22.5) and binge eating (18.5). Conversion to open was 1.7%: due to technical difficulties (1.2) and due to intraoperative complications (0.5). Together with the re-positioning of the band, additional surgery was performed in 11.9% of the patients: hiatal hernia repair (2.4), cholecystectomy (7.8) and other procedures (1.7). There was no mortality. Reoperation was required in 106 patients (5.9%): band removal 55 (3.7%), band repositioning 50 (2.7 %), and other 1 (0.05 %). Port-related complications occurred in 200 patients (11.2%). 41 patients (2.3%) underwent further surgery due to unsatisfactory results: removal of the band in 12 (0.7%), biliopancreatic diversion in 5 (0.27%) and a biliopancreatic diversion with gastric preservation ("bandinaro") in 24 (1.3%). Weight in kg was 103.7 +/- 21.6, 102.5 +/- 22.5, 105.0 +/- 23.6, 106.8 +/- 24.3, 103.3 +/- 26.2 and 101.4 +/- 27.1 at 1, 3, 5, 7, 9, 11 years after LAGB. BMI at the same intervals was 37.7 +/- 7.1, 37.2 +/- 7.2, 38.1 +/- 7.6, 38.5 +/- 7.9, 37.5 +/- 8.5 and 37.7 +/- 9.1. The case/control study found a statistically significant difference in survival in favor of the surgically-treated group., Conclusions: LAGB can achieve effective, safe and stable long-term weight loss. In experienced hands, the complication rate is low. Follow-up is paramount.

Background: We analyzed the role of high plasma ghrelin concentrations at surgery as a negative predictor of weight loss in morbidly obese patients treated with laparoscopic gastric banding (LAGB)., Methods: Fasting plasma ghrelin concentrations were measured in 113 women before LAGB, and 16 of them were identified as having ghrelin concentrations clearly higher than expected according to the BMI levels. The 2-year postoperative outcome of these 16 patients was compared to the outcome of the remaining subjects., Results: Mean fasting plasma ghrelin concentration in the group with hyperghrelinemia was 82.3+/-23.1 pg/ml and in women with normal ghrelin was 27.1+/-11.3 pg/ml (P<0.001). No differences in age, age at onset of obesity or degree of obesity were observed between the two groups. Women with hyperghrelinemia had a weight gain during the waiting time similar to women with normal ghrelin. The prevalence of comorbidities and eating behavior disturbances was similar in the two groups, but depression was 2.5 fold more prevalent in the hyperghrelinemic women than in the women with normal ghrelin. The %EWL after LAGB surgery was similar in women with high and normal ghrelin concentrations, with no differences in levels of postoperative band filling. No differences in band-related complications or revisional surgery rate were observed between the two groups., Conclusion: A high fasting ghrelin concentration at baseline did not significantly affect the outcome after LAGB in morbidly obese women, in terms of weight loss and complications rate.

Background: The authors investigated the outcome of morbidly obese patients with binge eating disorder (BED) treated surgically with laparoscopic adjustable gastric banding., Methods: The 5-year outcomes of 130 patients with BED and 249 patients without BED are described. The diagnosis of BED was made preoperatively and all patients with BED were supported with psychological therapy., Results: Patients with and without BED had similar BMI levels before surgery. More patients with than without BED had depressive symptoms and associated minor disturbances of eating behavior (night eating and grazing). Percent excess weight loss (%EWL) in the first 5 years after surgery was similar in patients with and without BED. The percentage of BED patients showing %EWL >50% at the 5-year evaluation was 23.1, and 25.7% in non-BED patients. The percentage of patients showing weight regain in the last 4 years of follow-up was similar in binge eaters (20.8%) and in non-binge eaters (22.5%). The 5-year frequency of gastric pouch and esophageal dilatation was significantly higher in binge eaters than in non-binge eaters (25.4 vs 17.7 %, P<0.05 and 10.0 vs 4.8%, P<0.05, respectively). Binge eaters underwent a higher number of postoperative band adjustments than non-binge eaters (3.0+/-2.1 vs 2.6+/-1.9, P<0.05) and the maximum band fill after surgery was higher in the BED patients than in non-BED patients (3.2+/-1.2 vs 2.8+/-1.3 ml, P<0.01)., Conclusion: Morbidly obese patients with BED supported by adequate psychological treatment can have good outcomes after gastric banding.

Background: The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed., Methods: Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed., Results: The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase., Conclusion: IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

Background: The authors investigated the usefulness of preoperative treatment with the BIB intragastric balloon in super-obese patients before undergoing laparoscopic adjustable gastric banding (LAGB)., Methods: The case-control study involved 43 case patients treated with the intragastric balloon followed by LAGB ("Case" group) and 43 sex-, age- and BMI-matched historical controls treated with LAGB alone., Results: Mean length of the intragastric balloon treatment was 164.4+/-39.7 days, with a fill volume of 609+/-95 ml. Total complication rate with balloon was 7.0% and percent excess weight loss (%EWL) was 26.1 +/- SD 9.3 %. At the time of gastric band placement, both operative time and hospital stay were shorter in patients treated previously with the balloon (Case group) than in the Control group patients. No Case patients required conversion to open surgery or had intraoperative complications. In the Control group, the rate of conversion was 16.3% (P<0.05) and the rate of intraoperative complications was 7.0%. Postoperative follow-up length was 1.1+/-1.0 years in Case patients and 4.4+/-1.8 years in Control patients (P<0.001). The %EWL produced by the intragastric balloon in the Case patients was identical to the %EWL observed in the first 6 months after LAGB in the Control group (26.1+/-9.3 vs 25.3+/-12.4%). %EWL 6 months after banding was higher in the Case patients than in Controls (33.6+/-12.5 vs 25.3+/-12.4%, P<0.01). However, no significant difference in %EWL between the two groups was observed at the subsequent postoperative evaluations., Conclusion: Preoperative treatment with the intragastric balloon reduced the risk of conversion to open surgery and the risk of intraoperative complications in super-obese patients treated with LAGB. Preoperative treatment with the intragastric balloon did not change the total weight loss after LAGB.

Background: The implantable gastric stimulator (IGS), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. We present our experience with 20 morbidly obese patients., Methods: Between September 20 and November 22, 2002, 20 patients (F/M 12/8), mean age 40.3 years (23-62) underwent IGS implantation. Mean BMI was 40.9 (33.9-48.2), mean weight 115.0 kg (87.0-137.0) and mean excess weight (EW) 51.3 kg (35.6-70.1).Co-morbitidies were: 3 cases of hypertension, 1 diabetes, 1 dislipidemia and 1 depression. Mean operative time was 58.5 min (37-85). The IGS was actived 30 days after implantation. Patients were advised to follow a low calorie diet and behavior modification (to avoid fat and to ingest more liquids during meals, to chew slowly, to eat vegetables before main meals, and to perform exercise daily)., Results: Mean +/- standard error percent excess weight loss (%EWL) was: 10.6+/-1.8 at 1 month; 15.0+/-2.3 at 2 months; 16.6+/-2.6 at 3 months; 18.1+/-3.5 at 4 months; 15.5+/-3.5 at 6 months; 18.9+/-3.5 at 8 months; and 23.8+/-5.0 at 10 months. There were no intra-operative surgical or long-term complications. There were 3 intra-operative gastric penetrations, observed by gastroscopy, without sequelae. One patient with hypertension ceased his medical therapy at the 4th month., Conclusion: IGS can be implanted laparoscopically with minimal perioperative complications. The observed weight loss is comparable to other noninvasive procedures. If weight loss is maintained, IGS could be considered as a first choice therapy in the treatment of morbid obesity in selected patients.

Background: The Lap-Band System is the most common bariatric operation world-wide. Current selection criteria do not include patients with BMI < or = 35. We report the Italian multicentre experience with BMI < or = 35 kg/m(2) over the last 5 years., Patients and Methods: Data were obtained from 27 centres involved in the Italian Collaborative Study Group for Lap-Band System. Detailed information was collected on a specially created electronic data sheet (MS Access 2000) on patients operated in Italy since January 1996. Items regarding patients with BMI < or = 35 were selected. Data were expressed as mean +/- SD except as otherwise indicated., Results: 225 (6.8%) out of 3,319 Lap-Band patients were recruited from the data-base. 15 patients, previously submitted to another bariatric procedure (BIB =14; VBG= 1) were excluded. 210 patients were eligible for study (34M/176F, mean age 38.19+/-11.8, range 17-66 years, mean BMI 33.9+/-1.1, range 25.1-35 kg/m(2), mean excess weight 29.5+/-7.1, range 8-41). 199 comorbidities were diagnosed preoperatively in 55/210 patients (26.2%). 1 patient (0.4%) (35 F) died 20 months postoperatively from sepsis following perforation of dilated gastric pouch. There were no conversions to laparotomy. Postoperative complications presented in 17/210 patients (8.1%). Follow-up was obtained at 6, 12, 24, 36, 48 and 60 months. At these time periods, mean BMI was 31.1+/-2.15, 29.7+/-2.19, 28.7+/-3.8, 26.7+/-4.3, 27.9+/-3.2, and 28.2+/-0.9 kg/m(2) respectively. Co-morbidities completely resolved 1 year postoperatively in 49/55 patients (89.1%). At 60 months follow-up, only 1 patient (0.4%) has a BMI >30., Conclusions: Although surgical indications for BMI < or = 35 remain questionable, the Lap-Band in this study demonstrated that all but 1 patient achieved normal weight, and most lost their co-morbidities with a very low mortality rate.

Background: The authors investigated the postoperative management of morbidly obese patients treated by laparoscopic adjustable gastric banding (LAGB) with the Lap-Band System., Methods: The 3-year postoperative band management is presented in 379 morbidly obese patients, divided according to intra-operative band filling and quartiles of maximum postoperative band filling., Results: LAGB resulted in a 40.8 +/- 24.5 percent excess weight loss (%EWL). Stoma stenosis occurred in 87 patients (23.0%), pouch dilatation in 52 (13.7%) and esophageal dilatation in 22 (5.8%). Most band-related complications were controlled by simple band deflation. The mean number of postoperative band adjustments was 2.3 +/- 1.7, and mean maximum band filling after surgery was 2.8 +/- 1.2 ml. Weight loss at 3 years was identical in 205 patients who had the band completely unfilled at surgery and in 174 patients who had the band filled with 1 to 3 ml of sterile saline. The rate of band-related complications was significantly lower in the first group. No differences in %EWL were observed between quartiles of maximum band filling after surgery. The rate of band-related complications increased with increasing levels of postoperative maximum band filling. In patients with the band filled with < 3.0 ml of sterile saline at 6 months, the inflation of further saline produced a dose-related increase in the rate of weight loss. In patients with the band filled with > 3.0 ml of sterile saline at 6 months, the inflation of further saline was associated with a reduced %EWL., Conclusion: Postoperative adjustability of the Lap-Band was useful in the treatment of band-related complications and was able to significantly influence the rate of weight loss. On the other hand, aggressive postoperative band filling was associated with an increased rate of complications.

Background: Laparoscopic adjustable gastric banding (LAGB) with the Lap-Band has been our first choice operation for morbid obesity since September 1993. Results in terms of complications and weight loss are analyzed., Methods: 830 consecutive patients (F 77.9%) underwent LAGB. Initial body weight was 127.9 +/- SD 23.9 kg, and body mass index (BMI) was 46.4 +/- 7.2 kg/m2. Mean age was 37.9 (15-65). Steps in LAGB were: 1) establishment of reference points for dissection (equator of the balloon inflated with 25 cc air and left crus); 2) creation of a retrogastric tunnel above the bursa omentalis; 3) creation of "virtual" pouch; 4) embedding the band., Results: Mortality was 0, conversion 2.7%, and follow-up 97%. Major complications requiring reoperation developed in 3.9% (36 patients). Early complications were 1 gastric perforation (requiring band removal) and 1 gastric slippage (requiring repositioning). Late complications included 17 stomach slippages (treated by band repositioning in 12 and band removal in 5), 9 malpositions (all treated by band repositioning), 4 gastric erosions by the band (all treated by band removal), 3 psychological intolerance (requiring band removal), and 1 HIV positive (band removed). A minor complication requiring reoperation in 91 patients (11%) was reservoir leakage. 20% of patients who had % excess weight loss < 30 had lost compliance to dietetic, psychological and surgical advice. BMI declined significantly from the initial 46.4 +/- 7.2 to 37.3 +/- 6.8 at 1 year, 36.4 +/- 6.9 at 2 years, 36.8 +/- 7.0 at 3 years, and 36.4 +/- 7.8 at 5 years., Conclusion: LAGB is a relatively safe and effective procedure.

Background: The authors investigated the outcome predictors in obese patients who underwent laparoscopic adjustable banding with the Lap-Band., Methods: The 3-year excess weight loss (EWL) and rate of band-related complications (pouch dilatation and port leakage) were analyzed in 260 morbidly obese patients, according to several possible predictive characteristics. Success rate (EWL > 50%), failure rate (EWL < 20%) and weight regain rate (regain of > 10% EWL between 1 and 3 yrs) were considered., Results: The Lap-Band produced a 43.0 +/- 22.3% EWL, corresponding to a BMI reduction from 46.6 +/- 7.0 to 36.8 +/- 6.6 kg/m2. Success rate was 35.7%, failure rate was 14.1% and weight regain rate was 20.7%. Pouch dilatation occurred in 32 patients (12.3%), band erosion in 2 (0.8%), port leakage in 74 (28.5%), and port twisting in 2 (0.8%). Major band-related surgery was requested in 11 patients (4.2%) and minor port-related surgery in 62 patients (23.9%). Significant success predictors were found to be age < 40 years and BMI < 50 kg/m2. Significant failure predictors were found to be male sex and non-sweet eating behavior. Significant weight regain predictors were found to be BMI < 50 kg/m2 and the occurrence of a port leakage. Port leakage was significantly more frequent in women and in patients with BMI < 50 kg/m2. The prevalence of pouch dilatation was threefold higher in women than in men., Conclusions: Lap-Band was associated with a good outcome and with a low rate of severe complications. The outcome was more influenced by physiological and technical reasons than by psychological or behavioural factors.

Background: An increasing number of surgeons with different levels of experience with laparoscopic surgery and open obesity surgery have started to perform laparoscopic implantation of the Lap-Band., Methods: An electronic patient data sheet was created and was mailed and e-mailed to all surgeons performing laparoscopic adjustable silicone gastric banding (LASGB) in Italy. Patients were recruited since January 1996. Data on 1,265 Lap-Band System operated patients (258 M/1,007 F; mean BMI 44.1, range 27.0-78.1; mean age 38, range 17-74 years) were collected from 23 surgeons performing this operation., Results: Intra-operative mortality was absent. Post-operative mortality was 0.55% (7 patients) for causes not specifically related to LASGB implantation. The laparotomic conversion rate was 1.7% (22 patients). LASGB related complications occurred in 143 patients (11.3%). Pouch dilatation was diagnosed in 65 (5.2%), and 28 (2.2%) of these underwent re-operation. Band erosion was observed in 24 patients (1.9%). Port or connecting tube-port complications occurred in 54 patients (4.2%), 12 of whom required revision under general anesthesia. Follow-up was obtained at 6, 12, 18, 24, 36 and 48 months, and mean BMI was respectively 38.4, 35.1, 33.1, 30.2, 32.1 and 31.5. The percentage of patients observed at each follow-up was > 60%. There was no intra-operative mortality and no complication-related mortality, with acceptable weight loss., Conclusion: The LASGB operation is safe and effective, and deserves wider use for treatment of morbid obesity.

Background: A moderate weight loss is known to improve the lipid levels in simple obesity. The extent of weight loss needed to achieve a clinically meaningful effect on lipid abnormalities in morbid obesity is little understood. We analyzed the effects of different levels of body weight loss on the lipid levels of morbidly obese patients operated with the LAP-BAND System., Methods: 225 morbidly obese patients (172 F and 53 M) in which a complete lipid profile has been collected both before and 12-18 months after surgery were studied. The changes of the lipid profile were analyzed according to different levels of percent weight loss (%WL: <10%, 10-20%, 20-30%, >30%)., Results: Mean weight loss was 30.7+/-15.2 kg, corresponding to a 23.1+/-9.7% reduction of body weight. A large variability in the weight loss was observed. A significant difference in the change of the lipid parameters between the group with <10%WL and the group with 10-20%WL was observed for total-cholesterol (+10.0+/-17.2% vs -0.7+/-14.7%; p<0.05), for the LDL (+18.7+/-26.3% vs +3.1+/-22.9%; p<0.05), and for the triglycerides (+7.7+/-26.3% vs -21.9+/-25.4%; p<0.05). No further significant differences were found between the two groups with greater weight loss (20-30%WL and >30%WL) and the group with 10-20%WL, the only exception being the percent change in triglycerides levels, i.e. higher in the group with %WL >30 (-33.6+/-31.5% vs -21.9+/-25.4%; p<0.05)., Conclusion: A moderate weight loss of 10-20% of initial body weight produced the maximal effects on the lipid levels in morbid obesity.

Background: In recent years, laparoscopic procedures have gained popularity. The laparoscopic technique is, however, more difficult than the conventional approach, especially in obese patients. The purpose of this article is to demonstrate a solution to these difficulties., Method: On September 16, 1998, a laparoscopic gastric banding procedure was performed by a surgeon while he was actually sitting at a distance from his patient. The surgeon's assistant was scrubbed and gowned and stood at the patient's side. The surgeon manipulated handles that were connected to a computer in command of robotic arms mounted on the operating table near the patient. The robotic arms contained surgical tools with articulated tips, well inside the abdominal cavity. The system constituted a master-slave construction called Mona (Intuitive Surgical, Mountain View, CA). The entire procedure (adjustable silicone gastric banding) was performed solely by this system without any other intervention., Results: The entire procedure lasted 90 minutes. The blood loss was 25 mL. The patient left the hospital on the second postoperative day., Conclusion: This procedure demonstrates that telesurgical procedures are feasible, can be performed safely even in obese patients, and improve the surgeon's comfort by restoring ergonomically acceptable conditions, by increasing the number of degrees of freedom, and by recreating the eye-hand connection lost in videoendoscopic procedures.

Background: The definition of success and failure of a bariatric procedure should include weight loss as well as improvement in comorbidity and quality of life assessment. The Bariatric Analysis and Reporting Outcome System (BAROS), introduced by Oria and Moorhead in 1997, seems to provide a standard for comparison in the surgical treatment of morbid obesity., Methods: 180 morbidly obese and super-obese patients, who underwent laparoscopic gastric banding (lap-band) at our institutions and had a follow-up >18 months (19-55 months) were evaluated with BAROS., Results: The patients were divided into four outcome groups (failure, fair, good, and excellent) based on a scoring table that adds or subtracts points while evaluating three main areas: percentage of excess weight loss, changes in medical conditions, and assessment of quality of life. Points were deducted for complications and reoperative surgery., Conclusions: The BAROS outcome system has proved to be a useful instrument in evaluating midterm results in our series of lap-band patients.

Objective: To evaluate the effects of a new timing strategy of band adjustment on the short-term outcome of obese women operated with adjustable silicone gastric banding., Subjects: The outcome of 30 women without binge-eating disorder operated with laparoscopic adjustable silicone gastric banding with a wider intraoperatory band calibration (LAP-BAND) was compared to that of 30 body mass index-matched women without binge-eating disorder previously operated with adjustable silicone gastric banding (ASGB) applied by laparotomy with the usual intraoperatory band calibration. The patients were evaluated 3, 6 and 12 months after surgery., Measurements: (1) weight loss; (2) total daily energy intake; (3) percent as liquid, soft or solid food; (4) vomiting frequency; (5) rate of postoperative percutaneous band adjustments; (6) rate of band-related complications., Results: Both the weight loss and the daily energy intake did not differ between patients with LAP-BAND and patients with ASGB. After surgery, the patients with LAP-BAND ate more solid food and less liquid food than the patients with ASGB. Vomiting frequency was higher in patients with ASGB than in patients with LAP-BAND. The total number of percutaneous band adjustments was higher in women with LAP-BAND than in women with ASGB. Band inflation because of weight stabilization was performed in six (20.0%) women with ASGB and in 19 (63.3%) women with LAP-BAND. Neostoma stenosis occurred in one woman with ASGB, but in none of the women with LAP-BAND. One patient with LAP-BAND presented band slippage., Conclusions: The wider intraoperatory band calibration performed in patients with LAP-BAND did not reduce the short-term efficacy of adjustable silicone gastric banding. This new timing strategy of band adjustment required more postoperative percutaneous band inflations, but it improved the eating pattern of the patients (low vomiting frequency and high intake of solid food).

Background: The laparoscopic application of LAP-BAND is gaining widespread acceptance as a gastric restrictive procedure. At the same time the reported morbidities (i.e., gastric perforation, stomach and/or band slippage) are cause for some concern., Methods: From September 1993 until May 1997, 260 patients underwent LAP-BAND at the Department of Surgery at the University of Padova, Italy., Results: The mortality rate was zero and the morbidity rate requiring reoperation was 3.4% (stomach slippage, gastric perforation, erosion). In order to avoid complications the key points of the technique are reviewed: (1) reference points for dissection (equator of the balloon, left crus); (2) retrogastric tunnel within the layers of the phrenogastric ligament; (3) embedment of the band; (4) proper outlet calibration; and (5) retention sutures., Conclusions: Attention to technical details is of paramount importance for a safe, standardized and effective operation.

BACKGROUND: Kuzmak's Adjustable Silicone Gastric Banding (ASGB) is the least invasive operation available for morbid obesity, and it is one of the more effective. Based on the know-how gained from performing more than 250 'open' procedures, we have developed an original laparoscopic technique, whose main steps are pouch measurement, limited dissection along the lesser and the greater curvature and the application of the retention sutures. METHODS: From September 1993 through October 1994, 30 morbidly obese patients underwent laparoscopic ASGB. RESULTS: Mean operative time was 2 h and the postoperative stay 2-3 days. Only one major perioperative complication (stomach slippage) was observed. The weight loss achieved, reported as a variation of Body Weight, Body Mass Index, per cent Ideal Body Weight and per cent Excess Weight Loss was similar to that obtained with the open procedure. CONCLUSION: This new approach is a major achievement in bariatric surgery, because it combines the minimal invasiveness of laparoscopy with the reversibility and adjustability of ASGB.

BACKGROUND: the authors describe a laparoscopic technique for the positioning of stoma adjustable silicone gastric banding (SASGB), which respects the main steps of the open procedure. METHODS: (1) patient position: supine with thighs abducted and 30 degrees reverse Trendelenburg; (2) Four 10 mm trocars (supra-umbilical, sub-xiphoid, right upper quadrant, left upper quadrant) and an 18 mm trocar (left subcostal); (3) exposure of the subcardial area; (4) measurement of the pouch; (5) dissection of the lesser and greater curvatures; (6) retrogastric tunnel; (7) introduction and placement of the band; (8) band closure and stoma calibration; (9) retention sutures. RESULTS: results obtained in a first (1992) series of five patients who underwent the laparoscopic application of the regular SASGB and results of a second series (1993-1994) of seven patients in whom the new LAP-ASGB was utilized are reported. CONCLUSION: this new approach can represent a major achievement in bariatric surgery, as it combines the minimal invasiveness of the laparoscopic approach with the reversibility of SASGB.

From April 1990 through December 1992, 111 patients (80 females, 31 males, mean age 38 years, range 16-60) underwent stoma adjustable silicone gastric banding (SASGB) at the Department of Surgery, University Hospital, Padua, Italy. Patients' characteristics were: mean height 166 +/- 8 cm; mean body weight (BW) 129.1 +/- 21.6 kg; mean body mass index (BMI) 46.4 +/- 6.3 kg/m(2); mean percentage of ideal body weight (%IBW) 206.2 +/- 27. Eighty-eight patients were morbidly obese and 23 superobese. All patients were available for follow-up. Median follow-up was 18.8 months (range 12-44). At I year (I 03 patients), mean postoperative BW, BMI, %IBW and excess weight lost (%EWL) were 101.5 +/- 20 kg, 36.5 +/- 6 kg/m(2), 164 +/- 30 and 40.8 +/- 19 respectively; at 2 years (58 patients) 92.3 +/- 19 kg, 33.1 +/- 6 kg/m(2), 148.8 +/- 28, 52 +/- 23, respectively, and at 3 years (26 patients) 86.9 +/- 14 kg, 31.4 +/- 5 kg/m(2), 141.5 +/- 25 and 63.6 +/- 20 respectively. The overall postoperative mortality rate was zero and the early morbidity rate 9%. Late complications were band slippage (two patients), stoma stenosis with pouch dilatation (seven patients), band erosion (one patient), reservoir leakage (three patients) and reservoir infection (two patients). Surgical revision was performed in ten (9%) patients, two of whom required band removal. Most complications occurred in patients who underwent SASGB during our initial experience. Our findings confirm that SASGB is a safe and effective surgical means of achieving weight reduction.

Adjustable silicone gastric banding (ASGB) is a recently introduced gastric restrictive procedure. From April 1990 to April 1992, 85 patients underwent ASGB at our Department. Patients' characteristics were: 65 females, 20 males, mean age 39.6 years (range 17-60 years); body weight (BW) 127.9 +/- 23 kg; % ideal body weight (%IBW) 205 +/- 29; body mass index (BMI) 46 +/- 7; morbidly obese 68, super-obese 17. Mean follow-up is 353 days. Twelve months after the operation BW was 95.2 +/- 23 kg, % loss of excess BW 52.1 +/- 22, and % IBW 152.2 +/- 30 (45 patients). Mortality rate was zero and postoperative morbidity was insignificant. As late morbidity, we experienced two slippages of the band and six stoma-stenosis with pouch dilatation. Therefore, a surgical revision without removal of the band was performed in eight patients. The band was removed in one patient because of band erosion. In conclusion, ASGB is a safe and effective bariatric procedure. The weight loss is comparable to that produced by more extensive operations. Moreover, ASGB is fully reversible and adjustable to the patients' needs.

Forty morbidly obese patients, scheduled for restrictive gastric surgery, were anaesthetized with two different techniques. In group A (20 patients) anesthesia was induced and maintained with Propofol (total intravenous anesthesia, TIVA); in group B (20 patients) anesthesia was induced with Thiopental and maintained with Isoflurane (balanced anesthesia). At the end of surgery, recovery time (RT) and recovery score (RS) were assessed according to a modified Aldrete score. There was no difference of RS between group A and group B. RT was shorter (though not statistically significant) in group A than in group B. Our experience suggests that both techniques can be safely used in these patients, but with TIVA, patients appeared more awake and cooperative earlier. Such an advantage may be useful to prevent serious complications (thromboembolism and pulmonary failure) in the postoperative period.